Vaginal ring sensor

ABSTRACT

A vaginal ring sensor device adapted to be placed within the vaginal vault of a user, the device including a ring body, at least one through hole that passes through the ring body, and at least one biosensor structured and arranged to sense and/or measure a parameter of vaginal fluid as such fluid passes through the at least one through hole.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/263,618 filed Sep. 13, 2016 (pending) which claims the benefit ofU.S. Provisional Patent Application Ser. No. 62/221,786 filed on Sep.22, 2015.

FIELD OF THE INVENTION

The present invention relates to a device for real-time biometricsensing and real-time biomarker sensing via a wet interface within thebody without tissue trauma. More particularly, the present inventionrelates to a ring shaped device for sensing biomarkers via a wetinterface within in the vaginal vault of a female.

BACKGROUND OF THE INVENTION

Advances in microelectronics, material science and wireless technologyhave led to the development of sensors that can be used for accuratemonitoring of previously inaccessible environments. Health monitoring,telemedicine, military and environmental monitoring are some of theapplications where sensors can be used. Sensors used in connection withhealth monitoring may be applied to the external surface of the body orimplanted inside the human body. Such sensors are referred to herein as“biosensors.” Biosensors may be used individually to monitor aparticular part of the body or multiple sensors can be used incombination to form a network and collectively monitor the healthcondition of their carrier or host. Biosensors are often implantedinside the human body because biomarker sensing via a wet interfacewithin the body may be required depending upon the particular biomarkerbeing sensed and/or measured. Implantation typically requires a surgicalprocedure with the accompanying risks associated with surgery.

Vaginal rings, i.e. ring shaped devices intended to be inserted into thevaginal vault are also well known in the art. Vaginal rings of the typetaught in the prior art are typically used either as drug deliverysystems or as core body temperature monitors. In general, these devicesare ring shaped, and comprise a pharmaceutically acceptable inertmaterial. In some embodiments, the vaginal rings are elastic so as to beeasily inserted into the vaginal vault of the user without a surgicalprocedure.

Some prior art vaginal rings intended for use as drug delivery systemshave been constructed to include blind holes and through holes which arefilled with the drug to be delivered to the vaginal region. The filledholes do not allow for flow of vaginal fluids through the body of thering.

In summary, although known biosensors may be used to monitor the healthcondition of their carrier or host they typically require invasivesurgical implantation if the monitoring of a wet interface is desired.Accordingly it is an objective of the present invention to provide abiosensor that can readily be placed within the body, in a location witha wet interface, without the need for surgical implantation.

SUMMARY OF THE INVENTION

The present invention provides, according to a first aspect of theinvention, a vaginal ring sensor device including a ring body, at leastone through hole that passes through the ring body, and at least onebiosensor structured and arranged to sense and/or measure a parameter ofvaginal fluid as such fluid passes through said at least one throughhole.

The present invention provides, according to a second aspect of theinvention, a vaginal ring sensor device including a ring body, aplurality of through holes that pass through the ring body, and at leastone biosensor structured and arranged to sense and/or measure aparameter of vaginal fluid as such fluid passes through at least one ofthe through holes.

The present invention provides, according to a third aspect of theinvention, a method of using a vaginal ring sensor device including thesteps of inserting a vaginal ring sensor device having at least onethrough hole the passes through a ring body of the vaginal ring sensordevice into the vaginal vault of a user, and measuring and/or sensing atleast one parameter of a vaginal fluid that passes through the at leastone through hole.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a vaginal ring sensor device according afirst embodiment of the present invention;

FIG. 2 is a cross-sectional view taken along line 2-2 of the vaginalring sensor device of FIG. 1;

FIG. 3 is a perspective view of a vaginal ring sensor device accordingto a second embodiment of the present invention;

FIG. 4 is a cross-sectional view taken along line 4-4 of the vaginalring sensor device of FIG. 3;

FIG. 5 is a perspective view of a vaginal ring sensor device accordingto a third embodiment of the present invention;

FIG. 6 is a cross-sectional view taken along line 6-6 of the vaginalring sensor device of FIG. 5; and

FIG. 7 is an illustration depicting a vaginal ring sensor deviceaccording to the present invention arranged within the vaginal vault ofa human female.

DETAILED DESCRIPTION OF THE INVENTION

Biosensors inserted within the human body can be used to sense biomarkerinformation via a wet interface within the body. One area inside thebody with wet interfaces is within the vaginal vault. There are manyfluids within the vaginal vault that can be used for wet interfacesensing. Some of these fluids include vaginal transudate, Bartholin'sand Skene's glands secretions, cervical mucus, exfoliated epithelialcells, and fluid from the uterus and endometrial tubes. The vaginal ringsensor device of the present invention is adapted to sense biomarkerinformation via the wet interface located within the vaginal vault.

A first embodiment of a vaginal ring sensor device 10 according to thepresent invention is shown in FIGS. 1 and 2. The vaginal ring sensordevice 10 includes a ring body 12 having a first surface 14 and a secondsurface 15. Second surface 15 is opposite first surface 14, and firstsurface 14 and second surface 15 may also be referred to as top 14 andbottom 15 surfaces, respectively. The vaginal ring sensor device 10further includes at least one through hole 20 that passes through thering body 12. In the embodiment of the invention shown in FIGS. 1 and 2the through hole 20 extends from the first surface 14 to the secondsurface 15. The through hole 20 includes a first opening 21 and aopposed second opening 23 . The through hole 20 functions to define athrough surface 22 extending through the ring body 12 from the firstopening 21 to the second opening 23. As shown in FIG. 2, in addition tohaving top 14 and bottom 15 surfaces, the ring body 12 also has an innersurface 16 and an outer surface 17. The ring 12 is preferably sized sothat it can be easily inserted into the vaginal vault of a female user,be securely retained within the vaginal vault during use, and easilyremoved by the user. For a human female, the ring 12 may have, forexample, a radius of 2 to 3 centimeters, wherein the radius “r” ismeasured from the center “C” of the hole 19 defined by the ring body 12to the outer surface 17 of ring body 12. The specific radius of ring 12may be selected to suit the particular anatomy of the user to maximizecomfort for the individual.

Through hole 20 is structured and arranged to allow the fluids withinthe vaginal area to flow through the ring body 12 immediately uponinsertion of the device 10 into the vaginal vault and throughout thetime that the user maintains the device 10 within the vaginal vault. Aswill be discussed in greater detail below, this structure allows for wetinterface sensing of the fluids in the vaginal area.

FIGS. 1 and 2 show vaginal ring sensor device 10 as having a ring body12 in the shape of a torus, that is a loop of material having a round,or circular, cross-section. Though shown as a torus, the ring body 12may be structured to have other shapes and other cross-sectionalprofiles. For example, the ring body 12 may be structured to have anoval, square, triangular, square, race track, or other suitable shape.Also the ring body 12 may be structured to have a cross-sectional shapethat is oval, race track, triangular, square, x-shaped, rectangular,rounded rectangle, or other suitable shape. The ring body 12 ispreferably sized so that its cross section, measures in the range fromabout 7 mm to about 10 mm. However these dimensions may be varieddepending upon the particular material characteristics of the materialused to form the ring body 12 and the anatomy and comfort considerationsof the individual user.

FIGS. 1 and 2 show vaginal ring sensor device 10 having at least onethrough 20. Other embodiments of vaginal ring sensor device 10 of thepresent invention may have a plurality of through holes 20, for exampleat least two, three, four, six, twelve, sixteen, twenty-four, or anynumber of through holes 20 as desired for the particular application ofthe invention.

FIGS. 1 and 2 depict the through hole 20 as having a round, or circularshape. However the through hole 20 may be structured and arranged tohave other shapes. For example, the through hole 20 may be structured tobe oval, race track, triangular, square, rectangular, rounded rectangle,or any other suitable shape that readily permits fluid to pass throughthe ring body 12 immediately upon insertion of the device 10 into thevaginal vault and throughout the time that the user maintains the device10 within the vaginal vault. In embodiments with multiple through holes20, the through holes 20 may have a variety of shapes, for example acombination of round and square through holes 20. In still otherembodiments, some or all through holes 20 may be tapered as they passfrom first surface 14 to second surface 15 of ring body 12 or viceversa.

As shown in FIG. 2, the vaginal ring sensor device 10 according to thepresent invention further includes at least one biosensor 26. Thebiosensor 26 is structured and arranged such that it can sense and/ormeasure a parameter of a fluid as such fluid passes through a throughhole 20. Preferably the biosensor 26 is arranged on the through surface22 of the ring body 12 between the first opening 21 and second opening23. In the particular embodiment of the invention depicted in FIG. 2 asingle biosensor 26 is arranged on the through surface 22 of the ringbody 12. However, other embodiments of the present invention may includetwo or more biosensors 26 arranged on the through surface 22 of the ringbody 12. In some embodiments of the present invention including multiplethrough holes 20 the ring sensor device 10 may include one, two or morebiosensors 26 arranged in a single through hole 20, while other throughholes 20 have no biosensors 26.

In the embodiment shown in FIG. 2, biosensor 26 is shown as partiallyembedded into the through surface 22 of the ring body 12. In this way,the material comprising ring body 12 will hold biosensor 26 in place. Inother embodiments, biosensor 26 may be secured to the through surface22. For example, adhesives may be used to keep the biosensor in place.In embodiments where biosensor 26 is embedded into the through surface22 of the ring body 12, the biosensors may be embedded during theprocessing of the vaginal ring sensor device 10 using techniques such asinsert molding. In still other embodiments, some biosensors 26 may bepartially embedded into the through surface 22 within some of thethrough holes 20, while other are secured to the through surface 22 ofsome of the through holes 20.

As shown in FIG. 2, the vaginal ring sensor device 10 may optionallyfurther include at least one biosensor 27 arranged on an outer surface17 of the ring body 12. In the particular embodiment of the inventiondepicted in FIG. 2 a single biosensor 27 is arranged on the outersurface 17 of the ring body 12. However, other embodiments of thepresent invention may include two or more biosensors 27 arranged on theouter surface 17 of the ring body 12. In the embodiment shown in FIG. 2,biosensor 27 is shown as partially embedded into the outer surface 17 ofthe ring body 12. In this way, the material comprising ring body 12 willhold biosensor 27 in place. In other embodiments, biosensor 27 may besecured to the outer surface 17. For example, adhesives may be used tokeep the biosensor 27 in place. In embodiments where biosensor 27 ispartially embedded into the outer surface 17 of the ring body 12, thebiosensor may be embedded during the processing of the ring body 12using techniques such as insert molding.

As shown in FIG. 2, the vaginal ring sensor device 10 may optionallyfurther include at least one biosensor 29 arranged on an inner surface16 of the ring body 12. In the particular embodiment of the inventiondepicted in FIG. 2 a single biosensor 29 is arranged on the innersurface 16 of the ring body 12. However, other embodiments of thepresent invention may include two or more biosensors 29 arranged on theinner surface 16 of the ring body 12. In the embodiment shown in FIG. 2,biosensor 29 is shown as partially embedded into the inner surface 16 ofthe ring body 12. In this way, the material comprising ring body 12 willhold biosensor 29 in place. In other embodiments, biosensor 29 may besecured to the inner surface 16. For example, adhesives may be used tokeep the biosensor 29 in place. In embodiments where biosensor 29 ispartially embedded into the inner surface 16 of the ring body 12, thebiosensor may be embedded during the processing of the ring body 12using techniques such as insert molding.

A second embodiment of a vaginal ring sensor device 100 according to thepresent invention is shown in FIGS. 3 and 4. FIGS. 3 and 4 show avaginal ring sensor device 100 having a plurality of through holes 120,and more particularly in the specific embodiment depicted, two throughholes 120. Other embodiments of vaginal ring sensor device 100 of thepresent invention may include any suitable number of through holes 120,for example at least three, four, six, twelve, sixteen, twenty-four, orany number of through holes 120 as desired for the particularapplication of the invention.

FIGS. 3 and 4 depict each of the through holes 120 as having a round, orcircular shape. However the through holes 120 may be structured andarranged to have other shapes. For example, the through holes 120 may bestructured to be oval, race track, triangular, square, rectangular,rounded rectangle, or any other suitable shape that readily permitsfluid to pass through the ring body 112 immediately upon insertion ofthe device 100 into the vaginal vault and throughout the time that theuser maintains the device 100 within the vaginal vault. In embodimentswith multiple through holes 120, the through holes 120 may have avariety of shapes, for example a combination of round and square throughholes 120. In still other embodiments, some or all through holes 120 maybe tapered as they pass from first surface 114 to second surface 115 ofring body 112 or vice versa.

As shown in FIG. 4, the vaginal ring sensor device 100 according to thepresent invention further includes at least one biosensor 126. Thebiosensor 126 is structured and arranged such that it can sense and/ormeasure of a parameter of a fluid as such fluid passes through a throughhole 120. Preferably the biosensor 126 is arranged on the throughsurface 122 of the ring body 112 between the first opening 121 andsecond opening 123. In the particular embodiment of the inventiondepicted in FIG. 4 a single biosensor 126 is arranged on the throughsurface 122 of the ring body 112. However, other embodiments of thepresent invention may include two or more biosensors 126 arranged on thethrough surface 122 of the ring body 112. In some embodiments of thepresent invention including multiple through holes 120 the ring sensordevice 100 may include one, two or more biosensors 126 arranged in asingle through hole 120, while other through holes 120 have nobiosensors 126.

In the embodiment shown in FIG. 4, biosensors 126 are shown as partiallyembedded into the through surface 122 of the ring body 112. In this way,the material comprising ring body 112 will hold biosensor 126 in place.In other embodiments, biosensors 126 may be secured to the throughsurface 122. For example, adhesives may be used to keep the biosensors126 in place. In embodiments where biosensors 126 are embedded into thethrough surface 122 of the ring body 112, the biosensors may be embeddedduring the processing of the vaginal ring sensor device 110 usingtechniques such as insert molding. In still other embodiments, somebiosensors 126 may be partially embedded into the through surface 122within some of the through holes 120, while other are secured to thethrough surface 122 of some of the through holes 120.

As shown in FIG. 4, the vaginal ring sensor device 100 may optionallyfurther include at least one biosensor 127 arranged on an outer surface117 of the ring body 120. In the particular embodiment of the inventiondepicted in FIG. 4 two biosensors 127 are arranged on the outer surface117 of the ring body 112. However, other embodiments of the presentinvention may include a single biosensor, or three or more biosensors127 arranged on the outer surface 117 of the ring body 112. In theembodiment shown in FIG. 4, biosensors 127 are shown as partiallyembedded into the outer surface 117 of the ring body 112. In this way,the material comprising ring body 112 will hold the biosensor 127 inplace. In other embodiments, biosensors 127 may be secured to the outersurface 117. For example, adhesives may be used to keep the biosensors127 in place. In embodiments where biosensors 127 are partially embeddedinto the outer surface 117 of the ring body 112, the biosensors may beembedded during the processing of the ring body 112 using techniquessuch as insert molding.

As shown in FIG. 4, the vaginal ring sensor device 100 may optionallyfurther include at least one biosensor 129 arranged on an inner surface116 of the ring body 112. In the particular embodiment of the inventiondepicted in FIG. 4 two biosensors 129 are arranged on the inner surface116 of the ring body 112. However, other embodiments of the presentinvention may include a single biosensor, or three or more biosensors129 arranged on the inner surface 116 of the ring body 112. In theembodiment shown in FIG. 4, biosensors 129 are shown as partiallyembedded into the inner surface 116 of the ring body 112. In this way,the material comprising ring body 112 will hold the biosensor 129 inplace. In other embodiments, biosensors 129 may be secured to the innersurface 116. For example, adhesives may be used to keep the biosensors129 in place. In embodiments where biosensors 129 are partially embeddedinto the inner surface 116 of the ring body 112, the biosensors may beembedded during the processing of the ring body 112 using techniquessuch as insert molding.

A third embodiment of a vaginal ring sensor device 200 according to thepresent invention is shown in FIGS. 5 and 6. FIGS. 5 and 6 show avaginal ring sensor device 200 having a plurality of through holes 220,and more particularly in the specific embodiment depicted four throughholes 220. Other embodiments of vaginal ring sensor device 200 of thepresent invention may include any suitable number of through holes 220,for example six, twelve, sixteen, twenty-four, or any number of throughholes 220 as desired for the particular application of the invention.

FIGS. 5 and 6 depict each of the through holes 220 as having a roundedrectangular shape. However the through holes 220 may be structured andarranged to have other shapes. For example, the through holes 220 may bestructured to be oval, race track, square, rectangular, or any othersuitable shape that readily permits fluid to pass through the ring body212 immediately upon insertion of the device 200 into the vaginal vaultand throughout the time that the user maintains the device 200 withinthe vaginal vault. In embodiments with multiple through holes 220, thethrough holes 220 may have a variety of shapes, for example acombination of round and square through holes 220. In still otherembodiments, some or all through holes 220 may be tapered as they passfrom first surface 214 to second surface 215 of ring body 212 or viceversa.

As shown in FIG. 6, the vaginal ring sensor device 200 according to thepresent invention further includes a first pair of biosensors 226 a.Each one of the biosensors 226 a is structured and arranged such that itcan sense and/or measure a parameter of a fluid as such fluid passesthrough a through hole 220. Each biosensor 226 a is arranged within arespective through hole 220, and specifically on an outer wall 225 ofthe through surface 222. In the particular embodiment shown in FIG. 6,each of the biosensors 226 a are arranged such that they aredirectionally aligned with one another, that is they are located withinthrough holes 220 that are directional aligned with one another onopposite sides of the ring body 212.

The vaginal ring sensor device 200 further includes a second pair ofbiosensors 226 b. Each biosensor 226 b is arranged within a respectivethrough hole 220, and specifically on an inner wall 228 of the throughsurface 222. In the particular embodiment shown in FIG. 6, each of thebiosensors 226 b are arranged such that they are directionally alignedwith one another, that is they are located within through holes 220 thatare directional aligned with one another on opposite sides of the ringbody 212.

As shown in FIG. 6, the vaginal ring sensor device 200 may optionallyfurther include at least one biosensor 227 arranged on an outer surface217 of the ring body 212. In the particular embodiment of the inventiondepicted in FIG. 6 two biosensors 227 are arranged on the outer surface217 of the ring body 212. In the particular embodiment of the inventionshown FIG. 6, each one of the biosensors 227 are directionally alignedwith one another, that is they are directionally aligned on oppositesides of the ring body 212.

As shown in FIG. 4, the vaginal ring sensor device 200 may optionallyfurther include at least one biosensor 229 arranged on an inner surface216 of the ring body 212. In the particular embodiment of the inventiondepicted in FIG. 6 two biosensors 229 are arranged on the inner surface216 of the ring body 212. In the particular embodiment of the inventionshown FIG. 6, each one of the biosensors 229 are directionally alignedwith one another, that is they are directionally aligned on oppositesides of the ring body 212.

The vaginal ring body 12, 112, or 212 of the invention may be comprisedof numerous pharmaceutically acceptable inert materials. Particularexamples of such a pharmaceutically acceptable inert material includepoly(ethylene-co-vinyl acetate) (PEVA), polyethylene (PE), polypropylene(PP), polyvinyl chloride (PVC), polyamide-imide (PAI), polyamide (PA),cross-linked polyethylene (PEX), thermoplastic elastomers (TPE),thermoplastic polyurethanes (TPUs), thermoplastic vulcanizates (TPVs),polybutylene terephthalate (PBT), polyester, poly(ethyleneterephthalate) (PET), silicone elastomers, cellulose derivatives,thermoplastic rubber, and polydimethylsiloxane, and copolymers andblends made with one or more of the above materials to name only a few.

The vaginal ring sensor device 10, 100, or 200 of the invention includeselectronics for sensing and/or measuring physiological parameters in thevaginal vault of a female user. “Electronics” generally refers to adevice incorporating a plurality of components, and includes large areaelectronics, printed wire boards, integrated circuits, component arrays,biological and/or chemical biosensors, and physical biosensors. Theelectronics may also comprise transmission components. The sensing andtransmission arrangement may be comprised by a flexible circuit boardarrangement. The flexible circuit board arrangement is size adapted tobe accommodated by or within the ring body 12, 112, or 212. The flexiblecircuit board arrangement can be a sensing element and a transmissionelement which is a miniature electronic circuit that generally cancomprise for example an antenna, a radio transmitter, a smallsilicon-based microcontroller with memory, and a single, or series ofbiosensors.

Vaginal ring sensor device 10, 100, or 200 can be an active radiofrequency device consistent with embodiments of the present invention.The flexible circuit board arrangement can support an active transmitterelement. The active transmitter element generally can comprise one ormore biosensors; conditioning circuitry that can include a number ofdiscrete components, such as capacitors, resistors, and diodes; a smallsilicon-based microcontroller that interfaces with the one or morebiosensors; solid state memory; a radio transmitter; battery and voltageregulation circuits; and an antenna. The radio transmitter can interfacewith the user, or with a health care professional via a computer,tablet, or smart phone.

The radio transmitter, of radio frequency (RF) device, can be a type ofelectronic data generating and memory device which can provide a meansfor measuring and providing information about the biosensor input. Thevaginal ring sensor device 10, 100, or 200 can be considered an activedevice when, in certain embodiments, it possesses its own discrete powersource, such as a battery. Such an active device can be programmed toperiodically transmit recently measured physiological measurements,periodically transmit several stored physiological readings or it canemit a signal containing its stored information whenever it enters andis queried by an RF field. In other embodiments, the radio transmitterassembly can be a passive radio frequency (RF) device. Unlike the activedevice described above, passive radio frequency transponder devices donot contain a power source. Rather, they generally operate in an RFIDenvironment and are inductively or capacitively powered when they enteran RF field. Once powered, the passive and/or optionally semi-passive(battery assisted) transponder Integrated Circuit (IC) can measurephysiological property and emit a signal containing this measuredinformation. Both active and passive radio frequency devices can includean analog circuit that detects and decodes data contained in theinterrogating RF signal providing data to the active or passive radiofrequency. The microcontroller circuit in the active device and digitalcircuitry contained in the transponder IC in the passive devicegenerally executes the data functions of the radio frequency sensor andtransmission device, such as measuring temperature, digitizing the dataand causing the digital data to modulate the RF signal to transmit themeasured data. In addition to retrieving and transmitting real-timemeasured data, both passive and active devices can permit new oradditional information to be written to a portion of the radio frequencydevice's memory, and/or, optionally, can permit the device to manipulatedata or perform some additional functions.

“Sensing” refers to detecting the presence, absence, amount, magnitudeor intensity of a physical and/or chemical property. Useful electronicdevice components for sensing include, but are not limited to electrodeelements, chemical or biological sensor elements, pH sensors,temperature sensors and capacitive sensors.

Biosensors 26, 27, 29, 126, 127, 129, 226 a, 226 b, 227, 229 may be usedfor sensing and/or measuring physiological parameters in the vaginalvault of a female user. Physical parameters may include, but are notlimited to: blood pressure, heart rate, pulse wave, pulse oximeter,temperature, or hydration.

The vaginal ring sensor device 10, 100, 200 of the invention may includea data storage device for recording the measured and/or sensedphysiological parameters until such time as the device is removed. Atsuch time the measured data may be transferred to from the ring sensordevice to a CPU or other tool for further analysis.

In some embodiments, temperature sensing can include a thermistor,Platinum Resistance Thermometer (PRT), other analog temperature sensoror, optionally, may be a temperature sensor with integrated digitalcircuitry that provides a digital output. Analogue temperature sensorscan include a Temperature Conditioning Circuit (TCC), which incorporateselectronic components that provide for proper voltage and output levelsfor the Analog to Digital (A/D) input to the microcontroller. If thetemperature sensor is a digital output device, it can be connecteddirectly to a Serial Programming Interface (SPI) bus or I2C busassociated with the microcontroller. In some embodiments, thetemperature sensor may be calibrated or, optionally, may have inherenttemperature measuring accuracy that facilitates an acceptabletemperature accuracy, such as to a +/−0.1 degree Celsius accuracy, forexample. Characteristics of the temperature sensor output function maybe programmed into the memory to improve accuracy.

Chemical parameters may also be sensed and/or measured by one or morebiosensors contained in the vaginal ring sensor device 10, 100, or 200.Biosensors may include electrochemical sensors and/or photometricsensors. In an exemplary embodiment, the biosensor may relate to aphotometric sensing of glucose concentration based on a fluorescencesensor typology. In another example, the biosensor may detect thepresence of reaction products from a glucose oxidase interaction withportions of the analyte biosensor and the fluid sample.

Concentration changes of analyte biomarkers can be monitored using theone or more biosensors. The monitoring of the biomarkers may occur at apredetermined frequency or upon demand through a user interface and/oran activation sensor in the device. Biomarkers can include thosecorrelated to glucose levels, depression, cardiac function, acute andchronic diseases, and such.

Vaginal ring sensor device 10, 100, or 200 and the user interface canalert the user, and/or a practitioner, of the sensed and/or measuredphysical and/or chemical property. The alert can be programmed to occurwhen the levels measured are outside the predetermined threshold valuesprogrammed, received and/or calculated by the device. In addition insome embodiments, the data and alerts may be analyzed to perform one ormore steps of: a) change measurement frequency according to the time ofthe day, b) identify personal patters in the changes of concentrationlevels measures, and c) change the measurement frequency according tothe changes in property measured.

In some embodiments, the time of the day may change the frequency ofmeasurements. For example, since device remains in the vaginal vaultduring sleep, the number of measurements during 10 PM and 6 AM candecrease or stop. Similarly, during lunch and dinner times the frequencymay increase to detect changes due to the food consumption of the user.Changes in physical and/or chemical property may be identified by thesystem. Using the identified patterns, the system may alert the user ofcauses and/or, change the frequency according to the identified changesso that the system is more alert during critical identified conditions.Critical conditions can include events that would trigger significantchanges in one or more physical and/or chemical property. Events caninclude, for example, holiday dates, exercise, location, time of theday, consumption of medicaments and the like.

In some embodiments, the originally programmed values may be customized,periodically or in real time, according to identifiedpatterns/conditions. This ability may allow the system to increase itseffectiveness by eliminating false alarms and increasing sensitivity ata critical condition. Effectiveness can promote user participation withthe system thereby maximizing the benefits of the device and therebyproviding a safe monitoring system. Data relating to the user including,for example, the identified patterns, measurements, and/or preferencesmay become part of the medical history of the user. Medical history maybe stored securely by encrypting the data and/or restricting its access.

In some embodiments, vaginal ring sensor device 10, 100, or 200 of theinvention may also have at least one depression or blind hole located onthe surface of the device. The depression or blind hole may contain atherapeutic, or active, agents for delivery to the vaginal vault,allowing the vaginal ring sensor device to act as a drug deliverydevice.

Therapeutic agents that may be used in conjunction with the vaginal ringsensor device 10, 100, or 200 described herein include, but are notlimited to: small molecules; proteins; peptides; nucleotides; nucleicacids; carbohydrates; simple sugars; cells; genes; anti-thrombotics;anti-metabolics; anticoagulants; antimitotics; fibrinolytics;anti-inflammatory steroids; monoclonal antibodies; vitamins; sedatives;steroids; hypnotics; antiinfectives, such as antibiotics and antiviralagents; chemotherapeutic agents (i.e., anticancer agents);prostaglandins, radiopharmaceuticals, anti-rejection agents; analgesics;anti-inflammatory agents; hormones, such as steroids; growth factors(inhibitors and promoters), such as epidermal growth factor, fibroblastgrowth factor, platelet-derived growth factor, insulin-like growthfactor, transforming growth factors, and vascular endothelial growthfactor; anti-angiogenic proteins such as endostatin; polysaccharides;glycoproteins; lipoproteins; and any combination of these.

FIG. 7 is a schematic diagram depicting the location an embodiment of avaginal ring sensor device 10 of the invention when placed in thevaginal vault 300 of a human female. The figure shows the anatomy of thepelvic region of a human female, including the rectum 310, vagina 320,the bladder 330, the uterus 340, the cervix 350, and ectocervix 355.Vaginal ring sensor device 10 is disposed on the ectocervix 355, whereit remains for the period of time for which it is in use. The vaginalring sensor device 10 is structured and arranged to adapt to the naturalexpansion and contraction of the cervix over the course of a woman'smonthly menstrual cycle, and thus can be comfortably worn throughout themenstrual cycle.

Vaginal ring sensor devices 10, 100, 200 according to the presentinvention may be placed in the vaginal vault of a human female by theuser herself, or may be placed by a medical professional such as adoctor, doctor's aide, nurse, or nurse practitioner. The vaginal ringsensor device 10 is designed to remain in place in the vaginal vault ofa human female for an extended period of time, allowing for themonitoring of physiological parameters in the vaginal vault of a femaleuser for an extended period of time. An extended period of time can begreater than two days, or one week, or one month, or three months, orsix months, one year or greater. Once inserted the vaginal ring sensor10, 100, 200 according to the present can sense and/or measure one ormore parameters of the vaginal fluid. The one or more sensed and/ormeasured parameters can be stored by the device and/or transmitted asdescribed above.

Accordingly, embodiments of the present invention may include a methodto use a vaginal ring sensor device including: inserting a vaginal ringsensor device having at least one through hole the passes through a ringbody of the vaginal ring sensor device into the vaginal vault of a user;and measuring and/or sensing at least one parameter of a vaginal fluidthat passes through the at least one through hole. The measuredparameter may be any one of a number of different physiologicalparameters including physical and chemical parameters. Of course asingle parameter may be sensed and/or measured or multiple parametersmay be sensed and/or measured. The method may further include storingand/or transmitting the sensed and/or measured parameter information.

Specific examples and method steps have been described herein to explainand enable different aspects of the present invention. These methodsteps and examples are for illustration purposes and are not intended tolimit the scope of the claims in any manner. Accordingly, thedescription is intended to embrace all embodiments that may be apparentto those skilled in the art.

We claim:
 1. A vaginal ring sensor device comprising: a ring bodyconfigured to be inserted and securely retained within the vaginal vaultof a user during use; at least one through hole that passes through thering body; at least one biosensor structured and arranged to senseand/or measure a parameter of vaginal fluid as such fluid passes throughsaid at least one through hole.
 2. The vaginal ring sensor deviceaccording to claim 1, wherein the ring body has the shape of a circle,rectangle, rounded rectangle, oval, square, triangle, race track, orsquare.
 3. The vaginal ring sensor device according to claim 1, whereinthe ring body has a circular, rectangular, rounded rectangular, oval,square, triangular, race track, square, or x-shaped cross-section. 4.The vaginal ring sensor device according to claim 1, wherein the atleast one through hole is structured and arranged to permit the flow offluids through the ring body immediately upon insertion of the deviceinto the vaginal vault of a female user.
 5. The vaginal ring sensordevice according to claim 3, wherein the cross-section of the ring bodymeasures from about 7 mm to about 10 mm.
 6. The vaginal ring sensordevice according to claim 1, wherein the through hole includes a firstopening and a second opening, the through hole defining a throughsurface extending through the ring body from the first opening to thesecond opening.
 7. The vaginal ring sensor device according to claim 1,wherein the ring body has a radius of from about 2 cm to about 3 cm asmeasured from a center of a hole defined by the ring body to an outersurface of the ring body.
 8. The vaginal ring sensor device according toclaim 1, wherein the at least one biosensor is partially embedded into awall of an through surface of the ring body.
 9. The vaginal ring sensordevice according to claim 1, wherein the at least one biosensor issecured to a wall of a through surface of the ring body.
 10. The vaginalring sensor device according to claim 1, further comprising at least onebiosensor arranged on an outer surface of the ring body.
 11. The vaginalring sensor device according to claim 1, further comprising at least onebiosensor arranged on an inner surface of the ring body.
 12. A vaginalring sensor device comprising: a ring body configured to be inserted andsecurely retained within the vaginal vault of a user during use; aplurality of through holes that pass through the ring body; at least onebiosensor structured and arranged to sense and/or measure a parameter ofvaginal fluid as such fluid passes through at least one of the throughholes.
 13. The vaginal ring sensor device according to claim 12, whereinthe ring body has the shape of a circle, rectangle, rounded rectangle,oval, square, triangle, race track, or square.
 14. The vaginal ringsensor device according to claim 12, wherein the ring body has acircular, rectangular, rounded rectangular, oval, square, triangular,race track, square, or x-shaped cross-section.
 15. The vaginal ringsensor device according to claim 12, wherein each of the plurality ofthrough holes is structured and arranged to permit the flow of fluidsthrough the ring body immediately upon insertion of the device into thevaginal vault of a female user.
 16. The vaginal ring sensor deviceaccording to claim 14, wherein the cross-section of the ring bodymeasures from about 7 mm to about 10 mm.
 17. The vaginal ring sensordevice according to claim 12, wherein each through hole includes a firstopening and a second opening, the through hole defining a throughsurface extending through the ring body from the first opening to thesecond opening.
 18. The vaginal ring sensor device according to claim12, wherein the ring body has a radius of from about 2 cm to about 3 cmas measured from a center of a hole defined by the ring body to an outersurface of the ring body.
 19. The vaginal ring sensor device accordingto claim 12, wherein the at least one biosensor is partially embeddedinto a wall of a through surface of the ring body.
 20. The vaginal ringsensor device according to claim 12, wherein the at least one biosensoris secured to a wall of a through surface of the ring body.
 21. Thevaginal ring sensor device according to claim 12, further comprising atleast one biosensor arranged on an outer surface of the ring body. 22.The vaginal ring sensor device according to claim 12, further comprisingat least one biosensor arranged on an inner surface of the ring body.23. The vaginal ring sensor device according to claim 12, wherein the atleast one biosensor comprises a plurality of biosensors, and whereineach one of said biosensors is structured and arranged to sense and/ormeasure a parameter of vaginal fluid as such fluid passes through one ofsaid plurality of through holes.
 24. The vaginal ring sensor deviceaccording to claim 12, wherein the at least one biosensor comprises afirst pair of biosensors.
 25. The vaginal ring sensor device accordingto claim 24, wherein each one of the first pair of biosensors is locatedwithin a respective one of a first pair of through holes.
 26. Thevaginal ring sensor device according to claim 25, wherein each one ofthe first pair of through holes is directionally aligned with the otherone of the first pair respective through holes on opposite sides of thering body.
 27. The vaginal ring sensor device according to claim 26,further comprising a second pair of biosensors.
 28. The vaginal ringsensor device according to claim 27, wherein each one of the second pairof biosensors is located within a respective one of a second pair ofthrough holes.
 29. The vaginal ring sensor device according to claim 28,wherein each one of the second pair of through holes is directionallyaligned with the other one of the second pair respective through holeson opposite sides of the ring body.
 30. The vaginal ring sensor deviceaccording to claim 12, further comprising at least one biosensorarranged on an outer surface of the ring body.
 31. The vaginal ringsensor device according to claim 12, further comprising at least onebiosensor arranged on an inner surface of the ring body.